Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months

Outcome Description:

The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.

Outcome Time Frame:

Baseline and 12 Months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Institutional Review Board

Study ID:

CZOL446EUS97

NCT ID:

NCT00104104

Start Date:

October 2004

Completion Date:

October 2007

Related Keywords:

• Multiple Myeloma
• Z-MAX, multiple myeloma, zoledronic acid, bone metastases
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Neoplasm Metastasis
• Bone Neoplasms
• Bone Marrow Diseases